Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized and open-label Phase II study to compare the safety, tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in high risk PCI patients.

Patients will receive standard treatment with acetylsalicylic acid (ASA) plus clopidogrel and heparin. Eligible patients will be randomly assigned to receive open-label study treatment with either ALX-0081 or ReoPro®. Patients will be stratified according to PCI type (elective or ad-hoc) and stent type (bare metal stent or drug eluting stent).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ablynx
• Treatments: Abciximab

Criteria

Inclusion Criteria:

• Have unstable angina or NSTEMI,or stable angina with at least 2 factors indicating a high risk PCI as follows: patient related: diabetic patients, renal failure (glomerular filtration rate < 60), reduced left ventricular ejection fraction < 35%, age > 75 years, female gender and/or lesion/anatomy related: SYNTAX score > 26, bifurcation lesions, multi-vessel disease, intracoronary thrombus.

• Adequate hematological function including platelets > 100000/mm3.

• Body mass index (BMI) ≥18 kg/m2 and ≤ 35 kg/m2.

• Aged ≥ 18 years old.

• Women of childbearing potential must be practicing a medically acceptable contraceptive regimen. Only males who do not want to father children during the study and in the first 4 months after treatment may be included in the study. During this period, safe contraception is mandatory. Male patients who are sexually active must use a condom during intercourse and ensure that the female partner uses a reliable contraceptive method, or they must refrain from sexual intercourse during the first 4 months after treatment.

• Patients must be accessible for follow-up.

• Have a sufficient command to read and understand all instructions necessary for giving informed consent and participating in the study.

• Have signed and dated written informed consent prior to any study-related procedures.

Exclusion Criteria:

• Previous (within 30 days) treatment with GPIIb/IIIa inhibitors (such as ReoPro®).

• ST-elevation myocardial infarction (STEMI).

• Chronic total occlusion of a coronary artery.

• Scheduled rotablator procedure.

• PCI of the arterial or venous by-pass graft.

• Any contra-indication for ReoPro®.

• Major organ dysfunction, infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.

• Known hypersensitivity to human/humanized antibodies.

• Women who are pregnant or lactating.

• Dementia or significantly altered mental status that would prohibit understanding the study procedures and giving informed consent.

• Use of vitamin K antagonists and/or Factor Xa inhibitors within 4 weeks prior to admission to the Hospital Intensive Care Unit.

• Use of GPIIa/IIIb inhibitors other than ReoPro®; prasugrel, bivalirudin and fondaparinux prior to and throughout the study.

• Known history of acquired or congenital bleeding disorder, coagulopathy or platelet disorder.

• Evidence of active pathological bleeding at screening or history of clinically significant bleeding (such as gastrointestinal or genitourinary) within the last 6 months prior to screening visit, unless the cause has been definitely corrected

• History of intracranial bleeding (e.g. hemorrhagic stroke, subdural hematoma, subarachnoid hemorrhage) or history of hemorrhagic retinopathy.

• History of ischemic stroke or TIA, within the past year prior to screening or known structural cerebral vascular lesion (e.g. arteriovenous malformation, aneurysm).

• History of New York Heart Association class III or IV congestive heart failure or history of severe, uncontrolled cardiac arrhythmias at screening.

• Planned elective surgical operation or major invasive procedures or traumas from 30 days prior to screening to completion of the study at Day 30 (the decision of what constitutes a major invasive procedure or trauma will be at the discretion of the investigator in conjunction with review and approval by the Medical Monitor).

• Use of another investigational drug or device within previous 30 days (12 weeks for investigational devices, e.g. unapproved stents) prior to screening.